کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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6240287 | 1280419 | 2016 | 7 صفحه PDF | دانلود رایگان |
BackgroundInhaled alpha1-proteinase inhibitor (PI) is known to reduce neutrophil elastase burden in some patients with CF. This phase 2a study was designed to test inhaled Alpha-1 HC, a new aerosolized alpha1-PI formulation, in CF patients.MethodsWe performed a randomized, double-blind, placebo-controlled study and evaluated the safety of 100 or 200Â mg of inhaled Alpha-1 HC once daily for 3Â weeks in subjects with CF. Thirty adult subjects were randomized in a 2:1 ratio to receive Alpha-1 HC or placebo.ResultsDrug delivery was confirmed by a dose-dependent increase in the sputum alpha1-PI. Seven (20.0%) of the 35 adverse events in the 100-mg dose group, 3 (13.0%) of 23 in the 200-mg dose group, and 4 (14.3%) of 28 in the placebo group were drug-related in these subjects. One serious adverse event occurred in 1 subject within each group.ConclusionsAlpha-1 HC inhalation was safe and well tolerated.
Journal: Journal of Cystic Fibrosis - Volume 15, Issue 2, March 2016, Pages 227-233